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Avanos Medical Recalls
57 recalls on record · November 20, 2019 to June 17, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 19, 2024Medical DevicesFDA
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSt
Hazard: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
June 19, 2024Medical DevicesFDA
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonS
Hazard: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
March 13, 2024Medical DevicesFDA
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -
Hazard: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
March 13, 2024Medical DevicesFDA
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec
Hazard: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
November 29, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me
Hazard: Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
September 27, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha
Hazard: Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
June 14, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls ambIT Cassette Filter Male Luer, Product Code: 220266
Hazard: Some of the ambIT kits were potentially distributed without an air in-line filter.
June 14, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Hazard: Some of the ambIT kits were potentially distributed without an air in-line filter.
June 14, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Hazard: Some of the ambIT kits were potentially distributed without an air in-line filter.
June 14, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Hazard: Some of the ambIT kits were potentially distributed without an air in-line filter.
June 14, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Hazard: Some of the ambIT kits were potentially distributed without an air in-line filter.
April 26, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Hazard: Incorrect expiration date.
March 22, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Hazard: Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
March 22, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Hazard: Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
November 16, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: S
Hazard: Sterile extension sets were distributed without an expiration date
May 25, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls Avanos Cortrak 2 Enteral Access System (EAS)
Hazard: Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
April 6, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Hazard: Product was distributed with incorrect expiration date.
April 6, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Hazard: Product was distributed with incorrect expiration date.
April 6, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Steril
Hazard: Product was distributed with incorrect expiration date.
February 16, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Hazard: The External Retention Bolster contained in the kit may be a larger diameter than the tube.
February 16, 2022Medical DevicesFDA
Avanos Medical, Inc. recalls MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Hazard: The External Retention Bolster contained in the kit may be a larger diameter than the tube.
December 16, 2020Medical DevicesFDA
Avanos Medical, Inc. recalls CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Hazard: Detachment of the Male AIV Adaptor from the Y-Connector.
September 23, 2020Medical DevicesFDA
Avanos Medical, Inc. recalls AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Hazard: Devices had cracked or detached from the feeding tube body
May 6, 2020Medical DevicesFDA
Avanos Medical, Inc. recalls CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Hazard: The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
January 15, 2020Medical DevicesFDA
Avanos Medical, Inc. recalls Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 10938230
Hazard: Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation.
November 20, 2019Medical DevicesFDA
Avanos Medical, Inc. recalls CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per cas
Hazard: The connector piece to the PEG tube does not pass over the guidewire.
November 20, 2019Medical DevicesFDA
Avanos Medical, Inc. recalls CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices coul
Hazard: The connector piece to the PEG tube does not pass over the guidewire.